Bioavailability of Medium Chain Triglycerides (MCTs) in Comatose Patients With Acute Brain Injury (ABI) (MCTs and ABI)

Nestlé

Status

Completed

Conditions

Injuries, Acute Brain

Subarachnoid Hemorrhage, Aneurysmal

Severe Trauma Brain Injury (sTBI)

Treatments

Dietary Supplement: Peptamen AF

Study type

Interventional

Funder types

Industry

Identifiers

NCT02716532

15.03.CLI

Details and patient eligibility

About

This study will be targeting patients suffering from acute brain injury (ABI), including those with severe trauma brain injury (sTBI) and those with aneurysmal sub arachnoid hemorrhage (aSAH).

This clinical study is an open-label, non-randomized, single-center, exploratory metabolic study.

The primary objective is to determine changes from baseline (before enteral administration of Peptamen AF) in plasma and brain extracellular levels of MCFAs and Ketone bodies in sTBI patients upon Peptamen AF nutritional support.

Enrollment

17 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Comatose patients (defined by an initial Glasgow Coma Scale (GCS) < 9) following sTBI or aSAH.
Female or male, aged >18.
Abnormal head CT-Scan (contusions, hematoma).
Intracranial monitoring with CMD, [PbtO2] and [ICP] probes as part of standard of care.
Written informed consent from an independent physician (not associated to the research project) who provides medical follow-up and defends patient's interests.
Written informed consent from patient relative/legal representative confirming the presumed patient willingness to participate in the study

Exclusion criteria

Signs of brain death or expected brain death within 48h.
Pregnancy.
Hemodynamic instability (circulatory shock, requiring vasopressors).
Renal or liver insufficiency .
Chronic intestinal disease.
Patients requiring parenteral nutrition .
Currently participating or having participated in another clinical trial during the month preceding the study